CalciMedica Halts Auxora Trial Amid Safety Concerns
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 28 2026
0mins
Should l Buy CALC?
Source: PRnewswire
CalciMedica Inc. has seen its stock price drop significantly, hitting a 52-week low in pre-market trading.
The company announced the suspension of its Phase 2 KOURAGE clinical trial for Auxora™ in acute kidney injury patients due to safety concerns raised by the Independent Data Monitoring Committee. Although no deaths related to Auxora or placebo were reported, the trial's suspension may impact future clinical evaluations and the company's stock performance. CalciMedica plans to conduct a comprehensive review of the clinical data to guide future testing of Auxora in acute kidney injury.
This development raises concerns about the company's clinical pipeline and could affect investor confidence moving forward.
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Analyst Views on CALC
Wall Street analysts forecast CALC stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.603
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Current: 0.603
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20.00
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About CALC
CalciMedica, Inc. is a clinical-stage biopharmaceutical company. The Company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. The Company's technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury. Its lead product candidate is Auxora, a potent and selective intravenous formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys. The Company is conducting a Phase IIb trial (called CARPO) for acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS), as well as supporting the ongoing Phase I/II asparaginase-induced pancreatic toxicity (AIPT) study (called CRSPA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
CalciMedica Reports FY GAAP EPS of -$1.97
- Financial Performance: CalciMedica's reported FY GAAP EPS of -$1.97 indicates significant challenges in profitability, which may negatively impact investor confidence and stock performance.
- Cash Position: As of December 31, 2025, the company holds $13.0 million in cash, cash equivalents, and short-term investments, suggesting a tight liquidity situation that necessitates careful cash management to sustain operations.
- Operational Outlook: The company expects its cash reserves to be sufficient to fund its current operating plan into the fourth quarter of 2026, providing a degree of safety but still requiring vigilance regarding future funding needs and market conditions.
- Market Reaction Potential: Despite the current poor financial performance, CalciMedica's future growth hinges on effective strategic execution and improvements in market conditions, prompting investors to closely monitor subsequent financial and operational developments.
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- Market Reaction Expectations: Analyst rating adjustments may lead to short-term volatility in the affected stocks, necessitating that investors closely monitor market dynamics to seize optimal trading opportunities.
- Source of Investment Advice: While the article does not provide specific stock names or rating details, investors can visit the analyst ratings page for a more comprehensive view of the information and recommendations available.
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CalciMedica Halts Auxora Clinical Trial Due to Safety Concerns
- Trial Suspension: CalciMedica has announced the suspension of its Phase 2 KOURAGE clinical trial for Auxora™ in acute kidney injury patients due to safety concerns raised by the Independent Data Monitoring Committee, which may impact future clinical evaluations.
- Data Analysis Plan: The company plans to conduct a comprehensive review of unblinded clinical data to assess the impact of baseline characteristics, disease severity, and other factors on patient outcomes, guiding future clinical testing of Auxora in AKI.
- Safety Assessment Results: No deaths related to Auxora or placebo were reported in the trial, and no serious adverse events met the criteria for expedited reporting to the FDA, indicating good safety for Auxora in over 350 critically ill patients.
- Future Trial Outlook: CalciMedica aims to finalize the pivotal trial design for Auxora in acute pancreatitis in the first half of 2026, pending FDA feedback, while also advancing CM5480 as a potential treatment for pulmonary arterial hypertension.
See More
CalciMedica (CALC) Anticipates Key Phase 2 Data Readout in 2026 with $14.1M Cash Position
- Clinical Trial Progress: CalciMedica's ongoing KOURAGE trial evaluating Auxora for acute kidney injury (AKI) is set to release key data in the first half of 2026, potentially providing significant support for the company's future development.
- FDA Trial Design Discussions: The company has engaged in positive discussions with the FDA regarding the pivotal trial design for acute pancreatitis (AP), with the final design expected in 1H 2026, laying the groundwork for subsequent clinical trials.
- Strong Financial Position: As of September 30, 2025, CalciMedica reported cash and short-term investments totaling $14.1 million, which is anticipated to fund operations into the second half of 2026, ensuring continuity in research and development activities.
- Stock Price Fluctuation: CALC's stock has traded between $1.42 and $7.20 over the past year, closing yesterday at $5.60, up 9.16%, and further rising to $5.78 in after-hours trading, reflecting market optimism regarding its future prospects.
See More
CalciMedica Reports FY GAAP EPS of -$1.97
- Financial Performance: CalciMedica's reported FY GAAP EPS of -$1.97 indicates significant challenges in profitability, which may negatively impact investor confidence and stock performance.
- Cash Position: As of December 31, 2025, the company holds $13.0 million in cash, cash equivalents, and short-term investments, suggesting a tight liquidity situation that necessitates careful cash management to sustain operations.
- Operational Outlook: The company expects its cash reserves to be sufficient to fund its current operating plan into the fourth quarter of 2026, providing a degree of safety but still requiring vigilance regarding future funding needs and market conditions.
- Market Reaction Potential: Despite the current poor financial performance, CalciMedica's future growth hinges on effective strategic execution and improvements in market conditions, prompting investors to closely monitor subsequent financial and operational developments.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several companies, reflecting varying market perspectives that could influence investor decisions and market trends.
- Upgrades and Downgrades: The rating changes include upgrades and downgrades for certain stocks, prompting investors to pay attention to these shifts to assess potential investment opportunities and risks.
- Market Reaction Expectations: Analyst rating adjustments may lead to short-term volatility in the affected stocks, necessitating that investors closely monitor market dynamics to seize optimal trading opportunities.
- Source of Investment Advice: While the article does not provide specific stock names or rating details, investors can visit the analyst ratings page for a more comprehensive view of the information and recommendations available.
See More
U.S. Stocks Mixed as Energy Shares Rise Amid Crude Inventory Decline
- Mixed Market Performance: U.S. stocks showed mixed results on Wednesday, with the S&P 500 falling approximately 0.1%, while the Dow Jones rose 0.02% to 49,012.75 points, indicating market uncertainty.
- Energy Sector Gains: Energy shares increased by 0.7% during Wednesday's trading, reflecting optimistic expectations for energy demand despite the overall market's poor performance.
- Crude Inventory Decline: U.S. crude stocks fell by 2.296 million barrels for the week ending January 23, significantly lower than the market's expected increase of 1.75 million barrels, suggesting supply constraints that could drive oil prices higher.
- Mortgage Applications Drop: The volume of mortgage applications decreased by 8.5% in the week ending January 23, indicating a weakening demand for home purchases that may impact the recovery of the real estate market.
See More
U.S. Stocks Mostly Higher; Starbucks Beats Q1 Sales Expectations
- Market Performance: U.S. stocks traded mostly higher on Wednesday, with the Nasdaq Composite gaining around 150 points and the S&P 500 rising 0.31% to 6,999.99, indicating positive market sentiment and increased investor confidence.
- Starbucks Earnings: Starbucks Corporation (NASDAQ:SBUX) shares rose about 5% on Wednesday, despite adjusted earnings of 56 cents per share missing market expectations of 59 cents, as sales of $9.915 billion exceeded expectations of $9.630 billion, showcasing strong sales growth.
- Sector Dynamics: Consumer discretionary stocks gained 0.9%, while healthcare stocks fell by 0.7%, reflecting a divergence in investor sentiment across different sectors, which may influence future investment strategies.
- Commodity Markets: Oil prices rose 1.3% to $63.19, gold increased by 3.7% to $5,272.90, and silver surged 8.4% to $114.830, indicating active commodity markets and heightened demand for safe-haven assets.
See More
CalciMedica Halts Auxora Clinical Trial Due to Safety Concerns
- Trial Suspension: CalciMedica has announced the suspension of its Phase 2 KOURAGE clinical trial for Auxora™ in acute kidney injury patients due to safety concerns raised by the Independent Data Monitoring Committee, which may impact future clinical evaluations.
- Data Analysis Plan: The company plans to conduct a comprehensive review of unblinded clinical data to assess the impact of baseline characteristics, disease severity, and other factors on patient outcomes, guiding future clinical testing of Auxora in AKI.
- Safety Assessment Results: No deaths related to Auxora or placebo were reported in the trial, and no serious adverse events met the criteria for expedited reporting to the FDA, indicating good safety for Auxora in over 350 critically ill patients.
- Future Trial Outlook: CalciMedica aims to finalize the pivotal trial design for Auxora in acute pancreatitis in the first half of 2026, pending FDA feedback, while also advancing CM5480 as a potential treatment for pulmonary arterial hypertension.
See More
CalciMedica (CALC) Anticipates Key Phase 2 Data Readout in 2026 with $14.1M Cash Position
- Clinical Trial Progress: CalciMedica's ongoing KOURAGE trial evaluating Auxora for acute kidney injury (AKI) is set to release key data in the first half of 2026, potentially providing significant support for the company's future development.
- FDA Trial Design Discussions: The company has engaged in positive discussions with the FDA regarding the pivotal trial design for acute pancreatitis (AP), with the final design expected in 1H 2026, laying the groundwork for subsequent clinical trials.
- Strong Financial Position: As of September 30, 2025, CalciMedica reported cash and short-term investments totaling $14.1 million, which is anticipated to fund operations into the second half of 2026, ensuring continuity in research and development activities.
- Stock Price Fluctuation: CALC's stock has traded between $1.42 and $7.20 over the past year, closing yesterday at $5.60, up 9.16%, and further rising to $5.78 in after-hours trading, reflecting market optimism regarding its future prospects.
See More
